Anti-Müllerian Hormone is Not Predictive of Pregnancy in Donor Insemination Cycles in Non-infertile Women

May 18, 2017 updated by: Iñaki González Foruria, Institut Universitari Dexeus

Ovarian Reserve Does Not Predict Pregnancy in Non-Infertile Women: An Assessment Using the Donor Sperm Insemination Model

To evaluate if ovarian reserve (measured by means of anti-mullerian hormone -AMH- and antral follicle count -AFC-) can predict pregnancy in donor insemination cycles (dIUI) performed in non-infertile women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

143

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Non Infertile women who undergo a donor sperm insemination due to absence of male partner or complete azoospermia or the presence of a genetic condition in the partner that made the couple opt for donor sperm.

Description

Inclusion Criteria:

  • absence of male partner
  • complete azoospermia or the presence of a genetic condition in the partner that made the couple opt for donor sperm
  • absence of previous history of infertility.
  • d ta on AMH and AFC assessment before the first dIUI cycle.

Exclusion Criteria:

  • previous history of infertility.

  • Presence of any gynaecological condition that could impair the inseminations results:

    • endometriosis, hydrosalpinx,…

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women who undergo donor sperm insemination
Non infertile women who undergo donor sperm insemination cycle
Diagnostic test: Anti Mullerian Hormone Measurement
Anti Mullerian Hormone was measured in all patients within two months before the first insemination cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Pregnancy
Time Frame: 6 weeks after insemination procedure
Clinical Pregnancy evaluated by ultrasound with fetal heart beat
6 weeks after insemination procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Miscarriage rate
Time Frame: Evaluated until 15 weeks after insemination procedure
Number of clinical miscarriage after clinical pregnancy
Evaluated until 15 weeks after insemination procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Universitari Dexeus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

June 30, 2016

Study Completion (Actual)

December 15, 2016

Study Registration Dates

First Submitted

May 18, 2017

First Submitted That Met QC Criteria

May 18, 2017

First Posted (Actual)

May 19, 2017

Study Record Updates

Last Update Posted (Actual)

May 19, 2017

Last Update Submitted That Met QC Criteria

May 18, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMD-2016-033

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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